Clearance Summary
CORONARY VEIN GRAFT TAG MARKER received FDA 510(k) clearance under submission number K971966, sponsored by Med-Edge, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1998-01-26.
- Submission: K971966
- Applicant / Sponsor: Med-Edge, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4650
- Decision date: 1998-01-26
Classification & Regulation
This clearance is catalogued under FDA product code KPK and 21 CFR 878.4650, within the General, Plastic Surgery review panel as a Class II device.